Study of the Emergence of Sensory Self-awareness in Premature Newborns Using the Rooting Reflex

NCT06365164 | Not Yet Recruiting

• 1 other identifier: 38RC23.0354
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to demonstrate the presence of the rooting reflex in premature and the emergence of sensory self-awareness in premature by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during quiet wakefulness. The main hypothesis is to confirm the tactile skills of the very premature newborn in exploring the rooting reflex and then to evaluate the emergence of sensory self-awareness. The investigators assume a difference in response in favour of a greater response of the newborn to external tactile stimulation compared to facilitated self-stimulation in favour of the distinction between self and non-self showing the emergence of a sensory awareness of self in the preterm newborn.

Conditions

Premature; Development, Child; Rooting Reflex

Keywords

rooting reflex; sensory self-awareness; tactile sensory; premature newborn; development care

Outcome Measures

Primary Outcomes (1)

• The emergence of sensory self-awareness in premature newborns by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during calm awakening.

  First the external stimulation procedure is 30-second phase of observation. Next, the experimenter touches the corner of the infant's mouth and repeatedly with his index finger (about 5 gentle touches of about 10 seconds, repeated about 5 times) depending on the state and commitment of the newborn, ending with a final observation period of 30 seconds. The facilitated self-stimulation procedure will begin and end with a 30-second observation period. Then the experimenter will place the newborn's elbow close to his body, allowing him to touch his face alone with his hand, on one side then the other, for 30 seconds, with 2 to 5 trials depending on the child's level of commitment. The coding use a qualitative scale of four behaviours from 1 to 4 that are increasingly representative of the rooting reflex. The primary outcome is defined by an average score of the relative frequencies representative of the rooting reflex and will be compared between the two stimulation conditions.

  The data will be collected for one year. Each newborn baby can be included for 14 weeks.The intervention is 5 to 10 minutes corresponding to external stimulation and facilitated self-stimulation spaced at least 2 hours apart and for up to 48 hours.

Secondary Outcomes (1)

• The secondary objective is to show a longitudinal progression in the emergence of the rooting reflex by repeated inclusions (seven days minimum) at different terms for the same newborn.

  Each subject will be able to take part in up to three interventions, each at least 7 days apart, until they reach 41 weeks' gestation. The data will be collected for one year. Each newborn baby can be included for 14 weeks.

Study Arms (1)

Premature newborns

Children born prematurely between 28 and 37 weeks of amenorrhoea, aged at least 3 days.

Behavioral: Tactile stimulation

Interventions

Tactile stimulation BEHAVIORAL

The procedure consists of brief perioral tactile stimulation. The procedure is filmed in order to record and evaluate the response of the newborn to the stimulation. During the same intervention, each newborn will receive external stimulation (the experimenter repeatedly and regularly touches the corner of the infant's mouth slowly with the tip of his index finger) followed by facilitated self-stimulation (the experimenter will place the newborn's elbow close to his body, allowing him to touch his face alone with his hand). There will also be an initial phase and a final 30-second phase in which the newborn is observed without any stimulation.

Premature newborns

Eligibility Criteria

• Age: 28 Weeks - 37 Weeks
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children born prematurely between 28 and 37 weeks of amenorrhoea, aged at least 3 days.

You may qualify if:

• Children born prematurely between 28 and 37 weeks of amenorrhoea, aged at least 3 days.

You may not qualify if:

• respiratory assistance (invasive or non-invasive ventilation)
• malformative syndrome
• a genetic syndrome
• neurological damage such as stage III or IV intraventricular haemorrhage or periventricular leukomalacia,
• sedative treatment: morphine, clonidine
• aminergic treatment
• acute pathology: shock, sepsis, acute cardiac failure, acute respiratory failure, etc.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Faculty of Psychology and Educational Sciences,University of Geneva: collaborator

Study Sites (1)

University Hospital Grenoble

Grenoble, Isere, 38 000, France

Location

Related Publications (3)

• Lejeune F, Marcus L, Berne-Audeoud F, Streri A, Debillon T, Gentaz E. Intermanual transfer of shapes in preterm human infants from 33 to 34 + 6 weeks postconceptional age. Child Dev. 2012 May-Jun;83(3):794-800. doi: 10.1111/j.1467-8624.2012.01753.x. Epub 2012 Mar 30.

  PMID: 22469180 BACKGROUND

• Marcus L, Lejeune F, Berne-Audeoud F, Gentaz E, Debillon T. Tactile sensory capacity of the preterm infant: manual perception of shape from 28 gestational weeks. Pediatrics. 2012 Jul;130(1):e88-94. doi: 10.1542/peds.2011-3357. Epub 2012 Jun 25.

  PMID: 22732168 BACKGROUND

• Als H, McAnulty GB. The Newborn Individualized Developmental Care and Assessment Program (NIDCAP) with Kangaroo Mother Care (KMC): Comprehensive Care for Preterm Infants. Curr Womens Health Rev. 2011 Aug;7(3):288-301. doi: 10.2174/157340411796355216.

  PMID: 25473384 BACKGROUND

Related Links

• Study of Rochat about rooting reflex and sensory awareness in newborns
• Touch in premature newborns

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Julia Doutau

  University Grenoble Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Doutau, Doctor

CONTACT

0476765577; jdoutau@chu-grenoble.fr

Alessia Touraton

CONTACT

0476765577; ATouraton@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 15, 2024
• Study Start: June 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: April 15, 2024

Record last verified: 2024-03

Locations

FR (1)